At Bristol Myers Squibb, we are inspired by a single vision transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change.
We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary / Objective Contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH / GCP, Regulatory Authorities' regulations / guidelines, and applicable SOPs / WPs.
Participates on one or more cross-functional study team(s) and / or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
Primarily works on routine to complex projects / trials at varying stages and supports multiple complex trials as needed.
Contributes to achieving corporate and study team goals, successfully completes assigned tasks, participates in service provider oversight, and sets priorities with guidance.
Proactively manages multiple assignments and operational processes with moderate to minimal supervision. Has high functional impact on the study team and the organization.
Functional area : crossing all therapeutic areas and research phases, collaborate with cross functional global teams to execute on assigned operational aspects of complex global clinical research studies from protocol development to final clinical study report.
Main Responsibilities Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following : Project Management : Provides operational input and facilitates in operational processes as a SME in support of the start-up maintenance and close out of studies.
Uses performance metrics and quality indicators to assist the Global Trial Manager in driving study execution. Proactively identifies potential risks and develops / implements actions to avoid or mitigate.
Resolves routine problems and escalates important issues appropriately and with a sense of urgency. Actively contributes as a key functional member on cross-functional teams.
Study / Project Planning, Conduct and Management : Provides and support input to study level tools and plans while working with moderate to minimal supervision.
Independently performs core GTS tasks and escalates / pushes back / delegates appropriately. Actively contributes to study meetings by leading some components.
Contributes to oversight of the required country regulatory (e.g., CTA, MoH) and country / site IRB / IEC approvals / notifications.
Flexibility to work on various trials at varying stages / complexity with minimal guidance as needed. Understands strategy and decision making at program level and their impact on the studies.
Ability to contribute to initiatives for process development and improvement. Ability to assess a situation and identify path forward with the appropriate resources.
Understands interdependencies of tasks assigned. Manages vendors and site payment processing and tracking. Facilitate the maintenance of study budget tracking tools and reconciles invoices with overall contract / budget and finance reports.
Knowledge and Experience Requirements BA / BS or Associate degree in relevant discipline Minimum 1-year experience in Clinical Research or related work experience.
Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems. Global experience is required.
Technical and Management Competencies : Knowledge of ICH / GCP, regulatory guidelines and directives, and the drug development process.
Knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred. Working knowledge of project management preferred.
Begin to network and foster relationships with key stakeholders across the study team. Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
Acts as a role model in supporting change within the organization and has knowledge of cross-functional partners who can help clarify change.
Mentors and coaches other team members and GTS’, as appropriate, and participate or provide leadership in departmental initiatives.
Builds relationships to achieve influence with others. Develops and maintains collaborative relationships with internal and external stakeholders to be more effective in the role.
Displays a willingness to challenge the status quo and take risks Effective oral and written communication skills, ability to across the matrix, organization, and to key stakeholders Travel : Less than 5% Around the world, we are passionate about making an impact on the lives of patients with serious diseases.
Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.